Fludarabine and Alemtuzumab or Cyclophosphamide Followed by Peripheral Blood Stem Cell Transplant or Alemtuzumab in Treating Patients With Advanced or Progressive Chronic Lymphocytic Leukemia (LLC0405)
This study has been completed.
Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT00462332
First received: April 18, 2007
Last updated: November 22, 2011
Last verified: November 2011
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Purpose
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. A peripheral stem cell transplant using stem cells from the patient or a donor may replace the patient's immune cells that were destroyed by chemotherapy.
PURPOSE: This phase II trial is studying how well giving fludarabine together with alemtuzumab or cyclophosphamide followed by peripheral blood stem cell transplant or alemtuzumab works in treating patients with advanced or progressive chronic lymphocytic leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Drug: Fludarabine Drug: Campath Procedure: Transplant |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Pilot Trial to Evaluate the Efficacy of a Combined Therapy Approach for Young CLL Patients With Advanced and Progressive Disease Stratified According to the Biological Prognostic Features |
Resource links provided by NLM:
Further study details as provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Primary Outcome Measures:
- Antitumor activity [ Time Frame: At 2 years from study entry ] [ Designated as safety issue: No ]Complete response and partial response
Secondary Outcome Measures:
- Toxicity [ Time Frame: At 2 years from study entry ] [ Designated as safety issue: Yes ]Number of AEs and SAEs
- Length of survival [ Time Frame: At 2 years from study entry ] [ Designated as safety issue: No ]
- Event-free survival [ Time Frame: At 2 years from study entry ] [ Designated as safety issue: No ]
- Disease-free survival [ Time Frame: At 2 years from study entry ] [ Designated as safety issue: No ]
| Enrollment: | 88 |
| Study Start Date: | May 2007 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: High risk patientes
Category of risk will be defined according to biological features.
|
Drug: Fludarabine
Induction therapy
Drug: Campath
Induction therapy
Procedure: Transplant
Post-induction therapy
Drug: Campath
Post-induction therapy
|
|
Experimental: Low risk patients
Category of risk will be defined according to biological features.
|
Drug: Fludarabine
Induction therapy
Drug: Campath
Induction therapy
Drug: Campath
Post-induction therapy
|
Show Detailed Description Eligibility| Ages Eligible for Study: | up to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of chronic lymphocytic leukemia (CLL)
- Advanced or progressive disease with ≥ 2 active clinical signs
PATIENT CHARACTERISTICS:
- Fertile patients must use adequate contraception
- No positive Coomb's test with signs of hemolysis
- No active infection
- No uncontrolled severe disease
- No known hypersensitivity or anaphylactic reactions to murine antibodies or proteins
- No other malignancies within the past 2 years except for adequately treated malignancies
- No significant traumatic injury within the past 4 weeks
- No coexisting medical or psychological condition that would limit study compliance
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior treatment for CLL
- No major surgery within the past 4 weeks
- No prior chemotherapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00462332
Locations
| Italy | |
| S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo | |
| Alessandria, Italy | |
| Universita Degli Studi di Bari | |
| Bari, Italy, 70124 | |
| Universita Cattolica del Sacro Cuore - Campobasso | |
| Campobasso, Italy, 86100 | |
| Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto" | |
| Catania, Italy, 95124 | |
| Ospedale Regionale A. Pugliese | |
| Catanzaro, Italy, 88100 | |
| Ospedale Civile Cosenza | |
| Cosenza, Italy, 87100 | |
| Universita di Ferrara | |
| Ferrara, Italy, 44100 | |
| Azienda Ospedaliera di Firenze | |
| Firenze, Italy, 50011 | |
| Ospedale San Martino | |
| Genova, Italy, 16132 | |
| ASL Le/1 P.O. Vito Fazzi - U.O. di Ematologia ed UTIE | |
| Lecce, Italy | |
| Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina | |
| Messina, Italy | |
| Azienda Ospedaliera Papardo | |
| Messina, Italy | |
| Ospedale Maggiore Policlinico | |
| Milano, Italy, 20122 | |
| Azienda Ospedaliera - Universitaria di Modena | |
| Modena, Italy, 41100 | |
| U.O. Ematologia Clinica - Azienda USL di Pescara | |
| Pescara, Italy | |
| Azienda Ospedaliera Bianchi Melacrino Morelli | |
| Reggio Calabria, Italy, 89100 | |
| Azienda Ospedaliera Universitaria Policlinico Tor Vergata | |
| Rome, Italy, 00133 | |
| Università Degli Studi "La Sapienza" | |
| Rome, Italy, 00161 | |
| Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore | |
| Rome, Italy, 00168 | |
| Ospedale Sant' Eugenio | |
| Rome, Italy, 00144 | |
| U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte" | |
| Siena, Italy | |
| Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino | |
| Turin, Italy, 10126 | |
| Policlinico Universitario Udine | |
| Udine, Italy, 33100 | |
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
| Principal Investigator: | Roberto Foa, MD | Universita Degli Studi "La Sapeinza" |
More Information
Additional Information:
No publications provided
| Responsible Party: | Gruppo Italiano Malattie EMatologiche dell'Adulto |
| ClinicalTrials.gov Identifier: | NCT00462332 History of Changes |
| Other Study ID Numbers: | LLC0405, LLC0405, 2005-002476-15 |
| Study First Received: | April 18, 2007 |
| Last Updated: | November 22, 2011 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
|
stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Fludarabine Fludarabine monophosphate |
Alemtuzumab Campath 1G Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013